Full Press Release Details
the year ended 30 June 2018
Limited ABN 80 063 114 045
Report- 30 June 2018
| Page | ||
| Corporate directory | 1 | |
| Intellectual property report | 6 | |
| Directors' report | 7 | |
| Auditor's independence declaration | 28 | |
| Financial statements | ||
| Consolidated statement of profit or loss and other comprehensive income | 29 | |
| Consolidated statement of financial position | 30 | |
| Consolidated statement of changes in equity | 31 | |
| Consolidated statement of cash flows | 32 | |
| Notes to the consolidated financial statements | 33 | |
| Directors' declaration | 68 | |
| Independent auditor's report to the members | 69 | |
| Shareholder information | 73 |
| Directors | Dr. Roger Aston |
| Independent non-executive chairman | |
| Mr. Daniel Pollock | |
| Independent non-executive director | |
| Mr. Stephen Anastasiou | |
| Independent non-executive director | |
| Mr. Peter Anastasiou | |
| Executive vice chairman | |
| Mr. Richard J Berman (appointed 1 July 2018) | |
| Independent non-executive director | |
| Secretary | Mr. Phillip Hains |
| Mr. Peter Vaughan (resigned 1 July, 2018) | |
| Interim Chief Executive Officer | Dr. Jerry Kanellos |
| Registered Office | Level 3, 62 Lygon Street |
| Carlton VIC 3053 | |
| Australia | |
| Telephone: +61(0)3 9824 5254 | |
| Facsimile: +61(0)3 9822 7735 | |
| Principal Place of Business | Unit 10, 25 - 37 Chapman Street |
| Blackburn North VIC 3130 | |
| Australia | |
| Telephone: +61 (0)3 9824 5254 | |
| Facsimile: +61 (0)3 9822 7735 | |
| Share Registry - Australia | Security Transfer Registrars Pty Ltd |
| 770 Canning Highway | |
| Applecross WA 6153 | |
| Australia | |
| Telephone: +61 (0)8 9315 2333 | |
| Facsimile: +61 (0)8 9315 2233 | |
| Share registry - United States | Bank of New York |
| 225 Liberty Street | |
| New York, NY 102286 | |
| United States of America | |
| Telephone: +1 212 495 1784 | |
| Auditors | Grant Thornton Audit Pty Ltd |
| Collins Square, Tower 1 | |
| 727 Collins Street | |
| Melbourne VIC 3008 | |
| Australia | |
| Telephone: +61 3 8320 2222 | |
| Solicitors - Australia | Francis Abourizk Lightowlers (FAL) |
| Level 16 | |
| 356 Collins Street | |
| Melbourne VIC 3000 | |
| Australia | |
| Telephone: +61 (0)3 9642 2252 | |
| Solicitors - United States | Carter Ledyard and Milburn LLP |
| 2 Wall Street | |
| New York NY 10005 | |
| United States of America | |
| Telephone: +1 212 238 8605 |
| Bankers | National Australia Bank (NAB) |
| 330 Collins Street | |
| Melbourne VIC 3000 Australia | |
| Securities exchange listings | Australian Securities Exchange (Code: IMC) |
| NASDAQ Exchange (Code: IMRN) | |
| Websites | www.Immuron.com |
| www.travelan.com.au |
clinical trial produces promising results
IMM-124E phase II Non-Alcoholic Steatohepatitis (NASH) clinical study has clearly demonstrated significant reductions in serum
Lipopolysaccharide (LPS), as well as reductions in other biomarkers associated with liver damage.
drug candidate IMM-124E, a first-in-class, oral antibody therapeutic targets the endotoxin LPS and other gram negative bacterial
components in the gut and prevents translocation into the blood circulation where they drive inflammation and cause damage to
the liver. The 24-week treatment study in Australia, Israel, and the US targeted 133 biopsy-proven NASH patients. The results
revealed nearly 64.3 per cent of IMM-24E-dosed patients showed a 15 per cent or greater decrease in serum LPS levels, compared
with just 34.5 per cent of patients showing a decrease in the placebo group.
the same time, the study showed decreases in both Aspartate Transaminase (AST and ALT) and Cytokeratin-18 (CK-18), metabolic markers
associated with NASH and liver damage.
reported results provide conformation of a unique mechanism of action and proof of concept that metabolic endotoxemia can be decreased
by using this drug candidate to prevent LPS translocating into the blood stream. Another expected but nonetheless pleasing outcome
was the confirmation that IMM-124E was retained within the gut lumen and was not absorbed systemically. This finding strengthened
IMM-124E's safety profile and potential for use in combination with other therapeutics.
is a severe form of non-alcoholic fatty liver disease (NAFLD). It represents an impending health crisis with between three and
five per cent of the US population affected, particularly through its obesity epidemic. Between two and four per cent of the global
population is also thought to be at risk. Projected annual costs of NASH treatment could reach USD25 billion by 2026.
expands commercial returns, extends therapeutic potential with US Defence study
the back of elevated sales for Travelan in the first half of 2017/18, the sales trajectory continued upward in the third quarter
in both the United States and Australia.
is Immuron's oral over-the-counter gastrointestinal and traveller's diarrhoea treatment.
Company's global gross sales reached AUD$2 million which resulted in 29% increase against the gross sales in 2017. In USA
alone, gross sales saw an increase of 114% over 2017. While in Australia, the gross sales managed an increase of 19% over 2017.
this trend continues, Travelan will continue to see an increase against the 2018 sales performance. With a sharp focus on a consistent
trade and pharmacy marketing program in both countries, and the expected addition of new territories to promote Travelan, sales
growth is projected to continue growing.
Department of Defense backs Travelan research
other Travelan news, a US Department of Defense-commissioned study has shown Travelan has effective immunological reactivity to
dangerous and potentially fatal infectious bacteria.
Department of Enteric Diseases (DED), Armed Forces Research Institute of Medical Sciences (AFRIMS) performed the study. It took
place at a laboratory of the Walter Reed Army Institute of Research (WRAIR) in Bangkok. WRAIR is one of the leading health research
organisations in the world.
study, one of three involving Travelan, looked at 60 clinical isolates of each of Campylobacter, Enterotoxigenic Escherichia coli
(ETEC), and Shigella from infected US Defence personnel in southeast Asia between 1993 and 2016. The study found that Travelan
antibodies were reactive to all 180 clinical isolates tested.
believe that our continuing collaborations with the DoD are a powerful validation of the potential of our platform to develop
novel anti-infectives.
patients enrolled in Clostridium difficile clinical study
29,000 annual deaths, and 450,000 people affected by Clostridium difficile infection (CDI) in the United States alone, the positive
progress of our IMM-529 CDI clinical trial is welcome news.
mostly strikes older people following the use of antibiotics, or extended periods of hospitalisation. It manifests in a range
of symptoms, from diarrhoea to potentially life-threating gut inflammation. Our clinical study will treat 60 patients diagnosed
with CDI, beginning with recruits at the Hadassah Medical Centre in Israel.
infected, patients face high rates of recurrence. The cost to the US healthcare system alone is estimated at $4.5 billion a year.
pre-clinical program successfully completed
May 2018, we announced the completion of our IMM-124 colitis preclinical mice program at the University of Zurich.
results follow in parallel with our NASH clinical study, which showed significant reductions in serum Lipopolysaccharide (LPS)
levels. LPS endotoxins are chief suspects in the inflammation associated with colitis and inflammatory bowel and other autoimmune
administration of IMM-124E was shown to successfully treat mice with colonoscopy confirmed immunologically induced colitis. The
results revealed that treatment with IMM-124E significantly reduced intestinal inflammation associated with colitis and produced
substantial reductions in weight loss, disease activity scores, shortening of the colon, and macroscopically detectable colitis.
believes IMM-124E may represent a novel therapeutic to induce and maintain remission in IBD patients. The findings of the University
of Zurich studies have been submitted for presentation at the annual United European Gastroenterology Week conference to be held
in Austria in October.
Liver Porfolio - Two Ongoing Phase 2 Programs in clinical development (ASH and Pediatric NAFLD)
Arun Sanyal is the lead Principle Investigator for the Immuron alcoholic steatohepatitis (ASH) clinical study which is funded
by the NIH. The study has enrolled 56 patients with severe alcoholic hepatitis and recruitment into the study has now been closed.
The primary endpoint is changes in ALT (liver enzymes) and topline results are expected in Q1 2019.
Liver Porfolio - Two Ongoing Phase 2 Programs in clinical development (ASH and Pediatric NAFLD) (continued)
17.3 percent of Americans aged 15 - 19 suffering NAFLD, Health authorities estimate paediatric NAFLD affects five to 10 percent
of the US paediatric population, with no current approved treatments. The lead Principle Investigator for our Paediatric NAFLD
study is Dr Miriam Vos, Emory University. Dr Vos specializes in the treatment of gastrointestinal disease in children as well
as fatty liver disease and obesity. Our NIH funded Phase II double blind, placebo control, randomized study on IMM-124E has enrolled
19 patients approximately 50% of the targeted 40 patients into the study. The primary endpoint is changes in ALT (liver enzymes)
following 3 months of treatment with top-line results expected in Q2 2019.
marketing and fundraising efforts step up
profile marketing via road-show appearances, analysts and investment conferences, and business television broadcasts continued
throughout the period.
January, Chief Executive Officer, Dr Jerry Kanellos was interviewed on the US Redchip Money Report, The Action Channel, and on
American Business TV's The Family Channel. The latter has access to 100 million homes in the US.
in January, he presented at the 10th Annual Biotech Showcase in San Francisco where he was able to meet with influential representatives
from investment and pharmaceutical circles.
March, we released a company presentation outlining all the latest developments across all of Immuron's platforms, as well
in April, Dr Kanellos presented at the monthly US Redchip Global Online Growth conference. The conference attracts large numbers
of analysts and investors - more than 12,000 participants attended the Redchip Global Online CEO conferences last year.
the Australian Government's Research and Development Income Tax Concession incentive scheme, Immuron received a AUD2.16
million cash refund. The payment rewarded our investment of more than AUD4.6 million in continuing R&D. The funds will go
towards accelerating timelines for pipeline programs.
mid March, we responded to market demand by completing a AUD5.1million private placement with a large US institutional investment
fund. The placement saw the issue of 13,162,744 new ASX shares. The funds will underpin current and future clinical programs,
support continued Travelan marketing, and secure working capital.
has appointed international firm Grant Thornton Audit Pty Ltd as auditors for both our Australian and US operations. Grant Thornton
Audit Pty Ltd replaced Marcum LLP in the US and William Buck Audit Pty Ltd in Australia.
Chief Executive Officer (CEO) Immuron Limited
Intellectual property report
has a policy to identify, capture and protect all relevant intellectual property associated within its core business strategies.
The company owns a number of patent families that have been filed to protect both the vaccine that is used to generate Immuron's
colostrum enriched with antibodies of choice, as well as methods of treating certain conditions with the resulting hyper-immune
colostrum. The company further maintains a significant register of trademarks, particularly in association with the product Travelan.
patent rights are supplemented by a comprehensive body of confidential and proprietary expertise that has been developed over
many years and relates to the methods of production of the hyper-immune colostrum. These trade secrets include information relating
to a low cost production system and an effective immunisation process that is approved by an independent animal ethics committee.
the year ended 30 June 2018, Immuron continued to progress its patent portfolio and has successfully prosecuted patents to Grant,
over various global jurisdictions.